Abstract
Background: Despite evidence of the effects of alirocumab on the incidence of acute coronary events, its impact on plaque stabilization remains uncertain. The present study will investigate the effect of alirocumab on fibroatheroma in patients who underwent recent percutaneous coronary intervention (PCI). Methods and Results: This phase IV, open-label, randomized, blinded near-infrared spectroscopy plus intravascular ultrasound (NIRS-IVUS) analysis, parallel-group, single-center study will enroll Japanese adults recently hospitalized for PCI with suboptimal low-density lipoprotein cholesterol (LDL-C) control (>70 mg/dL) despite stable statin therapy. Thirty patients will be randomized to receive either alirocumab or standard of care. The alirocumab group will receive alirocumab 75 mg every 2 weeks plus 10 mg rosuvastatin per day. The standard-of-care group will receive 10 mg rosuvastatin per day with dose adjustment to achieve LDL-C <70 mg/dL. Post-treatment NIRS-IVUS will be performed at week 36. The primary endpoint is the change in maximum lipid core burden index in 4-mm pullback compartments (maxLCBI[4 mm]) between baseline and week 36. Secondary endpoints include change in LCBI (lesion), angle of lipid core, plaque burden, and serum lipids and biomarkers related to atherosclerosis and inflammation. Conclusions: The study will clarify the effects of alirocumab on thin-cap fibroatheroma in patients who underwent recent PCI and who have suboptimal LDL-C control with stable statin therapy.